Health product recall

UniCel DxI 600 and 800 Access Immunoassay Systems

Last updated

Summary

Product
UniCel DxI 600 and 800 Access Immunoassay Systems
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

UniCel DxI 800 Access Immunoassay - Analyzer-Class 3

More than 10 numbers, contact manufacturer.

A71457

UniCel DxI 800 Access Immunoassay - Analyzer-Class 3

More than 10 numbers, contact manufacturer.

A71456

UniCel DxI 800 Access Immunoassay - Analyzer-Class 3

More than 10 numbers, contact manufacturer.

973100

UniCel DxI 600 Access Immunoassay Sys - Instrument W/ Spot B Gantry Class 2

More than 10 numbers, contact manufacturer.

A71460

UniCel DxI 600 Access Immunoassay Sys - Instrument W/ Spot B Gantry Class 2

More than 10 numbers, contact manufacturer.

A71461

UniCel DxI 600 Access Immunoassay Sys - Instrument W/Spot B Gantry Class 3

More than 10 numbers, contact manufacturer.

A71460

UniCel DxI 600 Access Immunoassay Sys - Instrument W/Spot B Gantry Class 3

More than 10 numbers, contact manufacturer.

A71461

UniCel DxI 600 Access Immunoassay System - Instrument Class 3

900950

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 3

902386

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 3

900807

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 3

901719

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 3

902624

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 3

900570

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 3

902385

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 3

902622

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 3

901684

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 3

902475

A30260

UniCel DxI 600 Access Immunoassay System

900950

A30260

UniCel DxI 600 Access Immunoassay System

902386

A30260

UniCel DxI 600 Access Immunoassay System

900807

A30260

UniCel DxI 600 Access Immunoassay System

901719

A30260

UniCel DxI 600 Access Immunoassay System

902624

A30260

UniCel DxI 600 Access Immunoassay System

902385

A30260

UniCel DxI 600 Access Immunoassay System

900570

A30260

UniCel DxI 600 Access Immunoassay System

902622

A30260

UniCel DxI 600 Access Immunoassay System

901684

A30260

UniCel DxI 600 Access Immunoassay System

902475

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 2

900950

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 2

902386

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 2

900807

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 2

901719

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 2

902624

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 2

900570

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 2

902385

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 2

902622

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 2

901684

A30260

UniCel DxI 600 Access Immunoassay System - Instrument Class 2

902475

A30260

UniCel DxI 800 Access Immunoassay System - Analyzer - Class II

More than 10 numbers, contact manufacturer.

A71457

UniCel DxI 800 Access Immunoassay System - Analyzer - Class II

More than 10 numbers, contact manufacturer.

A71456

UniCel DxI 800 Access Immunoassay System - Analyzer - Class II

More than 10 numbers, contact manufacturer.

973100

Issue

Beckman Coulter UniCel DxI 600 and 800 instruments fail to start after rebooting because the AuObj.exe software does not launch. A specific LED pattern on MCC cards confirms a hardware startup fault. This non-conformance requires FSE intervention.
 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Beckman Coulter, Inc.

250 S. Kraemer Blvd., Brea, California, United States, 92821

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81368

Get notified

Receive emails about new and updated recall and safety alerts.

Subscribe